Applicability and Effectiveness of Remote Occupational Therapy

Applicability and Effectiveness of Remote Occupational Therapy With Children and Adolescents With Dravet Syndrome and Their Families.

The pandemic has made it necessary to imagine and experiment with new ways for disabled patients to continue their care, responding to the sudden employment and emotional void of this historical period. With this in mind, several studies have shown how telemedicine and telerehabilitation can represent a new frontier in care, reducing costs, shortening distances, increasing continuity of care, and also allowing services to be performed in a comfortable and familiar environment. All these elements also combine to determine a positive effect on the patient's compliance with the therapeutic project, in which he or she finally feels like a protagonist. It is evident that the application of these modalities in the pediatric patient requires the maximum cooperation from the family. In this regard, it has been shown that despite the complexity associated with managing a patient with Dravet syndrome, families want to be involved, showing readiness to invest and participate in meaningful activities for their children.Considering the persistence of the national health emergency and the demonstrated effectiveness of remote occupational therapy in patients with behavioral and adaptive frameworks similar to Dravet patients, it is deemed interesting to test the feasibility of an occupational therapy project following the CO-OP approach (with the child or with the parent) also in this specific population. Moreover, when considering the care gap given by the small number of recognized professionals in the field of occupational therapy and the uneven distribution of such a service across the territory at the expense of rural and disadvantaged areas, remote occupational therapy could be a significant resource for families of children and youth with disabilities even beyond the boundaries of the current COVID emergency.

Study Overview

• Status: Completed
• Conditions: Dravet Syndrome

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

population selected from family association groups

Description

Inclusion Criteria:

• Diagnosis of Dravet Syndrome.
• Ages 7-18 years.
• Sufficient cognitive and behavioral skills to set goals and participate in treatment
• Access and manageability with respect to using a PC/tablet with a stable Internet connection
• Sufficient language/communication skills to follow simple instructions and interact with therapist
• Willingness/ability of a parent/caregiver in the family to attend all treatment sessions and involve themselves in "parent coaching." It will be necessary to maintain the same parent for the duration of the course.

Exclusion Criteria:

• Photosensitivity
• Organizational difficulties in the family that prevent the continuation of treatment
• Ongoing occupational treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients; Intervention Group 1 CO-OP with the patient
Parents; Intervention Group 2 CO-OP with the parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness of a remote occupational therapy	Evaluate the degree of improvement in self-perception of performance and satisfaction with goals achieved in therapy will be assessed during the clinical interview	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive-behavioral profile	Evaluate the results of any effects of the rehabilitation intervention on the cognitive-behavioral profile of patients, thanks to the standardised tests.	5 months
adaptive behavior.	Verify the effects of remote occupational therapy on patients' adaptive behavior in daily life activities, thanks to a questionnaire	5 months
QOLIE-31	Verify the effects of remote occupational therapy on patients' and their families' quality of life thanks to a questionnaire.	5 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Domenica Immacolata Battaglia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: occupational therapy; Dravet
• Additional Relevant MeSH Terms: Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epilepsy; Epilepsies, Myoclonic
• Other Study ID Numbers: 3982

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No